MitraClip in the ICCU: Which Patient will Benefit?

MitraClip in the ICCU: Which Patient will Benefit? DAVID MEERKIN STRUCTURAL A ND CONGENITAL HEART DISEASE UNIT SHAARE ZEDEK MEDICAL CENTER JERUSALEM

Conflict of Interest No relevant disclosures

Complex Question Which patients will achieve the most benefit from the procedure? Which patients will benefit at all from the procedure? Who won t benefit from MitraClip? For which patients is MitraClip the best procedure?

What is MitraClip?

Percent Patients Core Lab MR Grade at 1 Year (matched) EVEREST II and Continued Access High Surgical Risk Patients EVEREST II High Surgical Risk Patients (n=54 matched cases) Continued Access High Surgical Risk Patients (n=69 matched cases) 100 80 2+ 3+ p < 0.0001 1+ 100 80 2+ p < 0.0001 0+ 1+ 60 78% 60 3+ 83% 40 2+ 40 2+ 20 0 4+ 3+ 4+ 20 0 4+ 3+ 4+ Baseline 1 Year Baseline 1 Year Rinaldi SCAI 2011

Percent Patients NYHA Functional Class at 1 Year EVEREST II and Continued Access High Surgical Risk Patients EVEREST II High Surgical Risk Patients (n=54 matched cases) Continued Access High Surgical Risk Patients (n=89 matched cases) P < 0.0001 P < 0.0001 100 80 II I 100 80 I II I 60 40 III 74% II 60 40 III 84% II 20 0 IV Baseline III IV 1 Year 20 0 IV Baseline III IV 1 Year Rinaldi SCAI 2011

Maisano PCR 2012

Commercial MitraClip Implant Experience Treating Centers: 225 Patients 1 : 7,894 Implant Rate 1 : 96% Acute MR reduction 1,2 : 98% of implants Etiology Functional MR 67% Degenerative MR 23% Mixed 10% Etiology Mixed 10% DMR 23% FMR 67% 1. First-time procedures only. 2. Successful implants only. Data as of 5/31/2013. Source: Abbott Vascular.

The Problem Severe LV dysfunction with associated mitral incompetence is responsible for recurrent and prolonged hospital admissions The implementation of isolated surgical reduction of MR with no improvement of LV function is a challenging scenario

Functional MR LV Dysfunction Often very high surgical risk Surgery leads to clinical benefit High recurrence rate following successful MV repair Questionable survival benefit Interest in a safer and less invasive option

Heart Failure due to MR is Multifaceted

ACCESS-EU The ACCESS-EUROPE (ACCESS-EU) Study is a two-phase prospective, observational, multicenter, post-approval study of the MitraClip System for the treatment of significant MR ACCESS-EU Phase I enrollment started on October 2, 2008 and closed on April 13, 2011. The last follow-up occurred on June 15, 2012 ACCESS-EU Phase II was initiated on September 15, 2011 Butter et al EuroPCR 2013

Kaplan-Meier Freedom from Death 30 Days: FMR 97.1% DMR 94.0% 6 Months: FMR 88.3% DMR 88.9% 12 Months: FMR 81.8% DMR 82.5% At Risk 0 Day 30 Days 6 Months 12 Months FMR (N) 393 367 325 285 DMR (N) 117 111 103 89 p log-rank = 0.91

Kaplan-Meier Freedom from Surgery 30 Days: FMR 99.0% DMR 98.3% 6 Months: FMR 96.4% DMR 96.5% 12 Months: FMR 96.0% DMR 94.5% At Risk 0 Day 30 Days 6 Months 12 Months FMR (N) 393 364 316 277 DMR (N) 117 110 101 86 p log-rank = 0.48

Patients (%) Mitral Regurgitation Grade FMR N=219 Matched Cases DMR N=71 Matched Cases p < 0.0001 p = 0.0002 100% 80% 60% 79% 75% 40% 20% 0% Baseline 12 Months Baseline 12 Months

Patients (%) NYHA Functional Class FMR N=230 Matched Cases DMR N=78 Matched Cases p < 0.0001 p < 0.0001 100% 80% 60% 70% 81% 40% 20% 0% Baseline 12 Months Baseline 12 Months

Mean QoL Score (MLHFQ) Quality of Life Score (MLHFQ) 50 FMR N=186 Matched Cases DMR N=44 Matched Cases 40 30 20 42.8 29.3 39.9 26.6 10 Mean improvement -13.5 points 95% CI: (-16.4, -10.5) p<0.0001 Mean improvement -13.3 points 95% CI: (-19.3, -7.4) p<0.0001 0 Baseline 12 Months Baseline 12 Months

Mean Meters Walked 6-Minute Walk Distance 400 FMR N=140 Matched Cases DMR N=52 Matched Cases 300 200 280.0 331.5 246.2 323.6 100 0 Mean improvement 51.6 meters 95% CI: (32.5, 70.6) p<0.0001 Mean improvement 77.4 meters 95% CI: (44.2, 110.5) p<0.0001 Baseline 12 Months Baseline 12 Months

Considerations for Patient Selection Patient screening Suitable patient Suitable mitral valve anatomy Suitable monitoring possibilities

MitraClip Patient Selection Considerations Recommended criteria Moderate to severe MR (Grade 3 or more out of 4 grades) Pathology in A2-P2 area Coaptation length >2mm (depending on leaflet mobility) Coaptation depth <11mm Flail gap < 10mm Flail width < 15mm Mitral valve orifice area >4cm 2 (depending on leaflet mobility) Mobile leaflet length > 1cm 1. The current patient considerations are based on EVEREST II and commercial European experience to date. The MitraClip Patient Selection Coniderations document has been endorsed by the Crossroads faculty.

Mitral Valve Anatomy Anterior annulus Anterior leaflet Posterior leaflet Posterior annulus Chordae tendineae Lateral papillary muscle Medial papillary muscle The mitral valve apparatus includes the annulus, the leaflets, the chordae tendineae, and papillary muscles. modified from Carpentier, A. et al. Carpentier s Reconstructive Valve Surgery. Saunders Elsevier; 2010. The leaflets are normally asymmetric the anterior leaflet has a larger surface area, but occupies a smaller amount of annular circumference. (Foster GP et al. Accurate localization of mitral regurgitant Acute defects Cardiac using Care multiplane transesophageal echocardiography. Ann Thorac Jerusalem Surg 1998) 2013

Procedure

A good quality TEE LAX view is a strong indicator for good procedure guidance! Both AML and more important PML can be seen. Leaflet grasping and insertion can perfectly be observed in this case. Most Important Echo View: TEE LAX!

Rejected for MitraClip No suitable TEE quality, PML cannot be seen

Rejected for MitraClip Mitral valve stenosis (valve area < 4 cm²)

Rejected for MitraClip Barlow s disease, cleft

Malcoaptation

Malcoaptation

Calcified Leaflet Tip

Calcified Leaflet Tip

Screening Process TEE is mandatory for patient screening Significant MR? No severe calcification in mitral leaflet / annulus? No severe leaflet restriction? No too severe flail leaflet? No cleft between A2/P2? No prior surgery of mitral valve? No intracardiac mass or thrombus? No presence of mitral stenosis? All echo views for procedure guidance are obtainable and in good quality? YES! Good chance for technical / procedural success!

Patient Success Technical and procedural success Echocardiographic benefit Reduced MR LV remodelling Clinical benefit Reduced hospitalizations Improved Functional Class Impact of and on comorbidities

The Patient that Succeeds 59 year old man Diabetes, HTN, hypercholesterolemia 1998 AMI cath (TVD) -> CABG FC II Last two years: MR2+ -> 3+ Moderately impaired LV Function VF -> ICD Clinical deterioration FCIII -> FCIV Anasarca with bilateral pleural effusions Referred for MitraClip consideration

Echocardiography Severe MR Moderate LV dysfunction Not severe TIG 46mmHg Eccentric Jet Central Jet Orifice

Procedure Completion

6 Month Follow-up January 2013 Mild MR FC II Working full time Essentially unrestricted in daily function Thrilled!!

6 Months post

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